Cancer Concerns
On April 2, 2009, an FDA advisory panel reviewed the significance of malignant C-cell carcinoma and thyroid C-cell focal hyperplasia in rats and mice. Some say the tumors were caused by a nongenotoxic, specific receptor-mediated mechanism to which rodents are particularly sensitive, whereas nonhuman primates and humans are not.
The Victoza label carries a Black Box Warning:
| “ | Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza only to patients for whom the potential benefits are considered to outweigh the potential risk. | ” |
The FDA said serum calcitonin, a biomarker of medulliary thyroid cancer, was slightly increased in liraglutide patients, but still within normal ranges, and it required ongoing monitoring for 15 years in a cancer registry.
Novo Nordisk has reminded healthcare professionals of the serious risks associated with the use of Victoza. Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors in rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.
Read more about this topic: Liraglutide
Famous quotes containing the words cancer and/or concerns:
“I wish more and more that health were studied half as much as disease is. Why, with all the endowment of research against cancer is no study made of those who are free from cancer? Why not inquire what foods they eat, what habits of body and mind they cultivate? And why never study animals in health and natural surroundings? why always sickened and in an environment of strangeness and artificiality?”
—Sarah N. Cleghorn (1976–1959)
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—Henry David Thoreau (1817–1862)